The Effect of Cannabidiol in Learning and Memory of Adults

NCT06074172 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MD012420BM
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this study were to test if a singular dose of Cannabidiol (1) enhances the learning and memory of healthy human subjects, (2) test if Cannabidiol has negative effects on Retroactive and Proactive Interference during learning, (3) and test if demographic factors will influence CBD's modulation of human learning and memory.

Conditions

Memory

Outcome Measures

Primary Outcomes (5)

• Sum of Trials (I-V)

  Sum of Trials = Trial A1 + Trial A2 + Trial A3 + Trial A4 + Trial A5; Trial A1/A2/A3/A4/A5 are in reference to each trial in which list A is recalled during memory encoding. The score range for Sum of Trials is 0 to 75. A higher score is indicative of greater performance on the memory test and a lower score is indicative of lower performance on the memory test. Participants were instructed to listen to a list of 15 words (List A) read to them. Subjects were asked recall List A during five different trials (A1, A2, A3, A4, A5), with the words repeated to them after each trial. Participants were scored for the number of correctly repeated words for each trial.

  Each trial is 45 seconds for encoding and recall

• Proactive Interference Ratio (PI Ratio)

  PI Ratio = Trial B1/A1. Proactive interference is the tendency for previously learned information to affect to hinder learning of new information. A higher proactive interference ratio indicates protective effects on memory i.e. protection from interference during learning. A lower proactive interference is indicative of negative effects on memory caused from interference. Trial A1 is in reference to list A recall during the first trial. Trial B1 is in reference to list B recall. Highest score for each trial is 15 with a point awarded for each correctly recalled word from List A (15 words) and List B (15 words).

  Each trial is 45 seconds for encoding and recall

• Retroactive Interference Ratio (RI Ratio)

  RI Ratio = Trial A6/A5. Retroactive interference is the tendency for newly learned information to hinder the memory of previously learned information. A higher retroactive interference ratio indicates protection from interference during learning. A lower retroactive interference ratio is indicative of negative effects on memory caused from interference. Trial A6 is referring to delayed recall of list A; Trial A5 is referring to the fifth trial of list A recall. Highest score for each trial is 15 with a point awarded for each word correctly recalled from List A (15 words).

  Each trial is 45 seconds for encoding and recall

• Total Prose Recall

  Total Prose Recall = Immediate Recall + Delayed Recall; Recall of a prose story was done immediately then after a delay; Highest score for prose recall test is 25 with a point awarded for each item correctly recalled in the story (25 total items). A higher recall score is indicative of better memory.

  Each recall takes about 5 min for encoding and recall

• Montreal Cognitive Assessment Score

  Assessment of basal cognitive function; The range for Montreal Cognitive Assessment (MOCA) scores is 0 to 30. A higher recall score is indicative of better performance on the memory test. A lower recall score is indicative of worse performance on the memory test.

  10 minutes total for encoding and recall

Study Arms (2)

Placebo, Then Cannabidiol

PLACEBO COMPARATOR

Participants first received a Placebo 246 mg press pill during visit 1. After a washout period of 1 week, subjects received a Cannabidiol press pill during visit 2.

Drug: Placebo (246mg press pill)

Cannabidiol, Then Placebo

ACTIVE COMPARATOR

Participants first received a Cannabidiol 246 mg press pill during visit 1. After a washout period of 1 week, subjects received a Placebo press pill during visit 2.

Drug: Cannabidiol (246mg press pill)

Interventions

Cannabidiol (246mg press pill) DRUG

Cannabidiol press pills provided by Steve Goods CBD (Longmont, Colorado). CBD pills were tested by the chemistry lab at CSU Pueblo and by Botanacor in Denver, CO. Both laboratories determined CBD pills to be 99.98% pure with no THC, heavy metals, bacteria, and pesticides detected.

Cannabidiol, Then Placebo

Placebo (246mg press pill) DRUG

Placebo press pills were provided by Steve Goods CBD (Longmont, Colorado). Placebo pills were tested by the chemistry lab at CSU Pueblo and by Botanacar in Denver, CO. Both laboratories determined placebo pills to be pure with no heavy metals, bacteria, and pesticides detected.

Placebo, Then Cannabidiol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Were 18 years of age or older

You may not qualify if:

• Were pregnant or breast-feeding
• Had been diagnosed with mental illness
• Didn't speak English fluently
• Had severe hearing problems
• Had recreational or opioid drug contaminants in their urine
• Were involved in criminal activity

Sponsors & Collaborators

• Colorado State University: lead
• Institute of Cannabis Research: collaborator

Study Sites (1)

Colorado State University Pueblo

Pueblo, Colorado, 81001, United States

Location

Related Publications (1)

• Gebregzi HH, Zeiger JS, Smith JP, Stuyt L, Cullen L, Carsella J, Rogers DC, Lafebre J, Knalfec J, Vargas A, Diawara MM. Oral cannabidiol did not impair learning and memory in healthy adults. J Cannabis Res. 2025 Jan 23;7(1):5. doi: 10.1186/s42238-025-00262-2.

  PMID: 39849639 DERIVED

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Moussa Diawara
• Organization: Colorado State University Pueblo

Moussa.Diawara@csupueblo.edu

719-549-2813

Study Officials

• Moussa M Diawara, PhD

  Colorado State University-Pueblo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Care Provider, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm Case-Crossover

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 10, 2023
• Study Start: March 14, 2020
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available upon request.
• Access Criteria: Data will become available upon request.

Locations

US (1)